Sector outlook: Offering long-term rewards for patient investors
Overall, the fundamentals within the biotech sector remain strong. The sector arguably
remains one of the most structurally attractive long-term investment themes, due to
the pace of scientific breakthroughs, growing unmet medical needs and favourable valuation
entry points, which provide a strong foundation for long-term returns.
These favourable fundamentals have been reflected in a number of notable breakthroughs
across the past 18 months. For example, Akeso Biopharma/Summit Therapeutics’ ivonescimab
is a novel antibody therapy that holds promise in non-small cell lung cancer. In our
view, the drug candidate has the potential to dethrone Merck’s blockbuster Keytruda
(sales of c $29.5bn in 2024), having shown a 49% reduction in disease progression relative to Keytruda in the HARMONi-2 trial.
Another recent breakthrough was Axsome’s drug candidate AXS-05, which became the first
non-antipsychotic to show benefit in the challenging indication of Alzheimer’s disease
agitation, having demonstrated a 3.6-fold lower risk of relapse compared to placebo. These two examples correspond
to the therapeutic areas of oncology and neurology, respectively, which are the two
largest segments within the sector.
Oncology has long been the largest therapeutic area within biotech and pharma (c 25%
share), primarily driven by ongoing unmet medical needs in the space, with sales estimated
to reach c $356bn in 2030, up from c $189bn in 2023 (according to Evaluate Pharma).
Historically, cancer patients were reliant on surgery, radiation therapy and/or chemotherapy
to manage disease. However, the growth in the area has seen numerous new technologies
emerge. These include cell therapies, antibody-drug conjugates, bispecific antibodies,
personalised treatment regimens, radiopharmaceuticals and cancer vaccines. There has
also been a rise in new screening technologies and diagnostics, as well as patient
genetic sequencing to identify diseases more effectively.
Neurology follows oncology in terms of market share (c 10% share), and experiencing
a resurgence, in terms of both innovation and sector interest. There were four multi-billion-dollar
acquisitions in this field in the last 18 months: Intra-Cellular Therapies (by J&J
for $14.6bn, as mentioned above); Karuna Therapeutics (by Bristol Myers Squibb for $14.0bn); Cerevel Therapeutics (by AbbVie for $8.7bn); and Longboard Pharmaceuticals (by Lundbeck for $2.6bn). While neurology is considered one of the most complex areas of drug
development, the rate of advancements in recent months and years highlights the field
as one that is ripe for innovation, and since it is considered somewhat less competitive
than oncology, it presents ample opportunity for value creation.
Regulatory and political concerns seem overdone
Despite widespread concerns, in our view the outlook for the US FDA regulatory environment
remains positive, with the Trump administration seemingly keen to expedite the drug
approval process. There have been c 450 new approvals in the last eight years. The
rate of approvals began to increase from 2017 (the beginning of President Trump’s
first term in office), and 2024 saw the approval of 50 drugs and nine biologics. Encouragingly,
48% of the new drug approvals were first-in-class (those with novel pharmacological
effects), up from 36% in 2023. Given that smaller biotech companies are often the originators of the drugs that lead to such breakthroughs, this trend illustrates
the innovation and strong fundamentals within the sector, and we do not expect the
current momentum to be lost under the new administration. While budget cuts will reduce
the FDA’s headcount, there is no intention to cut the number of reviewers, so cuts
should not affect the pace of approvals.
Similarly, while the US political environment more generally has generated some uncertainties
for biotech investors, the reaction to these uncertainties seems excessive to us,
and any possible negatives are likely to be outweighed by the potential benefits of
President Trump’s second term. Aside from concerns about approvals, adverse influences
on sentiment have included the appointment of Robert F Kennedy Jr as US Secretary
of Health, but his vaccine scepticism is unlikely to influence drug development. In
addition, investors' concerns about mooted tariff increases are more likely to affect
larger pharma companies than biotech firms.
M&A set to increase over the coming years
In contrast, positive influences on the biotech sector include a likely increase in
M&A. This activity serves as the beating heart of the biotech sector. While there
has been a pause in M&A activity in recent months, we expect deals to increase over
the coming years, and this should provide some tailwinds to the biotech sector. Our
view is based on the fact that big pharma companies face a major patent cliff for
their blockbuster drugs over the remainder of this decade. It is estimated that there is over $200bn in annual revenue at risk as these patents expire, and,
hence, big pharma companies are in dire need of new drugs to replenish their clinical
pipelines and revenue streams. In addition, the recent departure of Lina Khan, the
former head of the Federal Trade Commission, weakens the constraints on M&A activity.
(For a more detailed discussion on this, we direct readers to our thematic piece.)
There also seems to be political support for innovation, as, generally speaking, President
Trump is pro-innovation and appears to want the industry to thrive, unencumbered by
excessive red tape, as the new administration has a longer-term goal to reduce regulatory
hurdles and expedite the drug approval process. Interest rates are a further key determinant
to activity in the sector and their current downward trajectory should be supportive
over time.
Collectively, these factors paint a positive long-term outlook for the biotech sector.
They also serve as a reminder of the longer time horizon associated with such investments,
compared to other sectors. While recent events have led to some volatility, overall,
associated uncertainties should eventually be offset by the biotech sector’s attractive
and supportive fundamentals. Investors will therefore need to exercise patience until
these fundamentals prevail over nearer-term market fluctuations.